Open-label Extension Study of Pramipexole in the Treatment of Children and Adolescents With Tourette Syndrome
NCT ID: NCT00681863
Last Updated: 2014-05-23
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
45 participants
INTERVENTIONAL
2008-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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pramipexole 0.0625 mg BID (twice daily)
all patients to receive one tablet of pramipexole 0.0625 mg BID for first 4 weeks (flexible dosing for all other arms)
pramipexole 0.0625 mg BID
0.0625 mg BID given for first 4 wks of treatment
pramipexole 0.0625 mg QD (once daily)
patients to receive one tablet of pramipexole 0.0625 mg QD
pramipexole 0.0625 mg QD
dose down titrated for those patients unable to tolerate the 0.0625 mg BID dosing
pramipexole 0.125 mg BID
patients to receive one tablet of pramipexole 0.125 mg BID
pramipexole 0.125 mg BID
titrated dose for those patients whose symptoms were not controlled on the 0.0625 mg BID dose
pramipexole 0.125 mg TID (three times daily)
patients to receive one tablet of pramipexole 0.125 mg TID
pramipexole 0.125 mg TID
titrated up for those patients whose symptoms were not adequately controlled on 0.125 mg BID dose
pramipexole 0.25 mg BID
patients to receive one tablet of pramipexole 0.25 mg BID
pramipexole 0.25 mg BID
titrated for those patients whose symptoms were not adequately controlled on 0.125 mg TID dose
Interventions
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pramipexole 0.125 mg BID
titrated dose for those patients whose symptoms were not controlled on the 0.0625 mg BID dose
pramipexole 0.0625 mg QD
dose down titrated for those patients unable to tolerate the 0.0625 mg BID dosing
pramipexole 0.125 mg TID
titrated up for those patients whose symptoms were not adequately controlled on 0.125 mg BID dose
pramipexole 0.25 mg BID
titrated for those patients whose symptoms were not adequately controlled on 0.125 mg TID dose
pramipexole 0.0625 mg BID
0.0625 mg BID given for first 4 wks of treatment
Eligibility Criteria
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Inclusion Criteria
2. Written informed consent provided by the patient's parent (or legal guardian) and assent provided by the patient consistent with International Conference on Harmonization (ICH) Good Clinical Practice (GCP) and local Institutional Review Board (IRB) requirements for children obtained prior to any study procedures being performed.
3. Ability and willingness to comply with study treatment regimen and to complete study assessments.
4. Females of childbearing potential having a negative serum pregnancy test at Visit 1.
5. Females of childbearing potential must be using a medically accepted contraceptive method throughout the study. Acceptable methods of birth control are limited to: Intra-Uterine Device (IUD), oral, implantable, injectable contraceptives or estrogen patch, double barrier method (spermicide + diaphragm), or abstinence at the discretion of the investigator
Exclusion Criteria
2. Development of any clinical condition in the preceding trial that in the investigator's opinion could be worsened by treatment with pramipexole.
3. Clinically significant renal disease or serum creatinine out of this range: 0.3 1.0 mg/dL for patients aged 3-12 years and 0.5-1.4 mg/dL for patients aged 13+ years.
4. Any of the following lab results at screening:
Hemoglobin (Hgb) below lower limit of normal (LLN) which is determined to be clinically significant Basal thyroid stimulating hormone (TSH), triiodothyronine (T3) or thyroxine (T4) clinically significant (at the investigator's discretion) out of normal range at screening (if not caused by substitution therapy according the investigator's opinion) Patients with any clinically significant abnormalities in laboratory parameters at screening at the investigator's discretion.
5. Other clinically significant metabolic-endocrine, hematological, gastrointestinal disease, or pulmonary disease (such as severe asthma) in the opinion of the investigator that would preclude the patient from participating in this study.
6. History or presence of schizophrenia or any psychotic disorder. History or presence of any psychiatric disorder requiring medical therapy with the exception for patients with a diagnosis of Tourette Syndrome (TS), Attention Deficit Hyperactivity Disorder (ADHD) or Obsessive Compulsive Disorder (OCD) who are not on therapy other than pramipexole.
7. History or presence of clinical signs of epilepsy or seizures other than fever-related seizures in early childhood.
8. History or presence of clinical signs of any malignant neoplasm including suspicious undiagnosed skin lesion (which may be melanoma), melanoma, or a history of melanoma.
9. History of any other medical treatment for TS besides the study medication within 28 days prior to the baseline visit (14 days prior to baseline for guanfacine, 14 days prior to baseline for dopamine agonists, 14 days prior to baseline for L-Dopa, 35 days prior to baseline for fluoxetine).
10. Patients receiving psychotherapy are excluded unless they started the treatment at least 3 months prior to starting the trial and no changes in treatment are planned for the duration of the study.
11. Allergic response to pramipexole or the inactive ingredients in its tablet formulation.
12. Non-compliance with study medication (defined as less than 80% or more than 120%) during the preceding Study 248.641 or 248.644.
13. Concurrent participation in another clinical trial using any investigational drug since completion of the preceding Study 248.641 or 248.644.
14. Any other conditions, that in the opinion of the investigator, would interfere with the evaluation of the results or constitute a health hazard for the patient.
6 Years
17 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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248.642.0026 Boehringer Ingelheim Investigational Site
Bradenton, Florida, United States
248.642.0025 Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
248.642.0006 Boehringer Ingelheim Investigational Site
Columbus, Georgia, United States
248.642.0005 Boehringer Ingelheim Investigational Site
Cambridge, Massachusetts, United States
248.642.0003 Boehringer Ingelheim Investigational Site
Manhasset, New York, United States
248.642.0009 Boehringer Ingelheim Investigational Site
New York, New York, United States
248.642.0018 Boehringer Ingelheim Investigational Site
New York, New York, United States
248.642.0013 Boehringer Ingelheim Investigational Site
Orangeburg, New York, United States
248.642.0029 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
248.642.0010 Boehringer Ingelheim Investigational Site
Providence, Rhode Island, United States
248.642.0030 Boehringer Ingelheim Investigational Site
Memphis, Tennessee, United States
248.642.0008 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
248.642.0023 Boehringer Ingelheim Investigational Site
Norfolk, Virginia, United States
248.642.49004 Boehringer Ingelheim Investigational Site
Ulm, , Germany
Countries
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Other Identifiers
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2008-000342-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
248.642
Identifier Type: -
Identifier Source: org_study_id
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